NATIONAL CONFERENCE ON MEDICAL DEVICES

INNOVATION AND RESEARCH FOR NEW PRODUCTS AND

SERVICES IN THE BIOMEDICAL SECTOR

INTRODUCTION

The Italian Medical Device industry accounts for 5.8% of total spending on health care and represents the third-largest market in Europe; it is mainly made up of small companies (74% do not go beyond a turnover per year of 20 k euro), located primarily in central northern Italy.

Emilia Romagna is the highest ranking Italian region in terms of the number of people employed in the biomedical sector, while Modena is the foremost Italian province both in terms of workforce size and the value of exports, followed by Milan and Bologna.

The Mirandola Biomedical District is today considered the world’s third-largest hub in this industry; the most important specialisation continues to be disposables and haemodialysis equipment, for which Mirandola can boast a position of leadership at the international level. In addition to dialysis, other important sectors are cardiac surgery, transfusion/autotransfusion and anaesthesia/intensive care.

The potential for development of companies in the biomedical district can be further reinforced by their ability to use the results of institutional research and link their own competences with those of the university and health care system with the objective of identifying new paths of product and process innovation and generating new manufacturing units capable of placing on the market new products/services that are the fruits of research, being able to rely on:

• the Health Care Enterprises of the Province of Modena (Local Health Unit and University - Hospital Polyclinic of Modena), which are on in a forefront position in terms of quality and the multiple technological resources in their possession and suitably qualified to concretely assess technologies, manage safety and clinical risk, verify effectiveness and analyse the cost-effectiveness of health services;

• the University of Modena and Reggio Emilia, above all its Faculties of Medicine and Surgery and Biosciences and Biotechnologies, which have achieved research results in the sector of genetic therapies with adult stem cells that are extremely advanced at an international level. The University has developed and made available sophisticated research technologies for studying the interactions between biological systems and materials used for biomedical devices and boasts significant experience in designing and conducting controlled clinical trials. It moreover aims to broaden and further knowledge at all levels with respect to biomedical technologies and their potential uses in clinical practice.

In order to lend concrete form to all of this, a protocol of agreement called Quality Center Network was renewed on 30 July 2007. The agreement was signed between the business associations of the Mirandola biomedical district, the University - Hospital Polyclinic of Modena, the Modena Local Health Unit, the University of Modena and Reggio Emilia, the Provincial Authority of Modena, the Unione dei Comuni Modenesi Area Nord (Union of Municipalities of the Province of Modena – Northern Area) and Democenter-Sipe (Innovation and Technology Transfer Centre of the Province of Modena).

The aim of the agreement is precisely to structure a relationship of collaboration among the partners and set up an information and front office desk for companies in the biomedical industry, dedicated to aspects regarding technology and innovation transfer based on optimal exploitation of institutional and company research, clinical and pre-clinical assessments and trials and validation of technologies and products.

Said aim is pursued through:

• establishment and formalisation of a continuous partnership with national and regional public health care institutions, in particular with: the Ministry of Health, The Department of Health Policy of the Region of Emilia Romagna and the “Area Vasta Emilia Nord” (northern Emilia health district), which embraces the health care enterprises of the Provinces of Modena, Reggio Emilia, Parma and Piacenza, aimed at favouring technological innovation and at the same time exploring topics connected to public procurement policies regarding biomedical products;

• start-up of a partnership with the newly established Osservatorio per l’Innovazione dell’Agenzia Sanitaria Regionale (Regional Health Agency Innovation Monitor) of the Region of Emilia Romagna, in order that innovative technologies developed by companies in the province of Modena can be assessed from the standpoint of their actual relevance and clinical, organisational and economic impact;

• creation of a front office and information desk managed by DemoCenter-Sipe, its function being to serve as a link between the manufacturing world and the health care and research realms and provide support to companies in the biomedical sector in their development, clinical and pre-clinical trial and product validation processes through operational networking between companies and health care and research institutions, with a particular focus on the needs of less structured enterprises;

• formalisation, through a specific protocol of agreement, of the collaborative relationships and operational procedures to be started up between the above-mentioned desk and the research and innovation units in the process of being set up in the Health Care Enterprises and the Departments and Offices of the University of Modena and Reggio Emilia;

• planning of a permanent activity of promotion and organisation of educational and guidance programs geared toward high school students and undergraduate, graduate and post-graduate students of the University of Modena and Reggio Emilia, in collaboration with the businesses in the biomedical district.

In order to favour achievement of the above-described aim, one initiative that the Quality Center Network intends to undertake beginning in 2010 is the organisation of a biennial national conference aimed at spotlighting the future scenarios in the fields of research and innovation in the biomedical sector and investigating market repercussions and funding opportunities for favouring industrial research and development.

In order to illustrate what is expected from the Conference, below we list the working sessions planned for the first Conference:

• session 1: the future of medicine and health; introductory session of discussion focused on the health care of tomorrow, on defining scenarios for the next 10 – 20 years in the various sectors of medicine and welfare systems, indicating, on a macro level, where innovation is going and will go above all in the diagnostic – therapeutic and rehabilitation sectors and highlighting the relationships to the biomedical sector;

• session 2: innovation and transferability; session of discussion about innovation centred on the technological transfer of research and how it is possible to generate and optimally exploit know-how in the biomedical industry, with a priority focus on sectors of innovation which are developing in the Region of Emilia Romagna in universities, research laboratories and manufacturing enterprises, an illustration of case histories of success and an exchange of views among “science business” experts;

• session 3: governing technological innovation and sources of funding; a session focused on the decision-making process at a regional and company level with respect to the choice and methods of supplying innovative technologies, illustrating funding opportunities for research and industrial development existing in the public sector and financial markets.